未经许可的美国干细胞产品的诉讼

IF 19.8 1区医学 Q1 CELL & TISSUE ENGINEERING

Cell stem cell Pub Date : 2025-05-01 DOI:10.1016/j.stem.2025.04.001

Branden Lee, Noah Brookes, Adam S. Levin

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引用次数: 0

摘要

针对未经批准的干细胞干预的财务处置已显著增长，成功的集体诉讼、医疗事故索赔和政府机构之间的合作起诉。除了改进处理方式，联邦巡回法院一致肯定了FDA对干细胞干预的监管权力，为监管建立了重要的先例。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Litigation of unlicensed US stem cell products

Financial dispositions against unapproved stem cell interventions have grown significantly, with successful class-action lawsuits, malpractice claims, and collaborative prosecutions between government agencies. In addition to improved dispositions, federal circuit courts have given unanimous affirmation to the FDA’s regulatory authority over stem cell interventions, establishing critical precedents for oversight.

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来源期刊

Cell stem cell 生物-细胞生物学

CiteScore

37.10

自引率

2.50%

发文量

151

审稿时长

42 days

期刊介绍： Cell Stem Cell is a comprehensive journal covering the entire spectrum of stem cell biology. It encompasses various topics, including embryonic stem cells, pluripotency, germline stem cells, tissue-specific stem cells, differentiation, epigenetics, genomics, cancer stem cells, stem cell niches, disease models, nuclear transfer technology, bioengineering, drug discovery, in vivo imaging, therapeutic applications, regenerative medicine, clinical insights, research policies, ethical considerations, and technical innovations. The journal welcomes studies from any model system providing insights into stem cell biology, with a focus on human stem cells. It publishes research reports of significant importance, along with review and analysis articles covering diverse aspects of stem cell research.